Exagis: Our Proprietary CDMS Supporting Your Clinical Trials

Exagis, far more than a data-collection tool

Developed in-house since 2012, Exagis is Axiodis's purpose-built CDMS. Unlike the generic solutions on the market, Exagis was designed by Data Managers and biostatisticians working day to day on clinical trials. Every feature meets a real, field-tested need, validated across hundreds of studies.

The platform manages the entire lifecycle of clinical data: from the design of data-entry forms through to database lock, taking in query management, centralised monitoring and export to the CDISC analytical formats.

HDS hosting and uncompromising regulatory compliance

Exagis is hosted in France in an environment certified as a Health Data Host (Hébergeur de Données de Santé, HDS). This certification guarantees that patient data remains on French territory, in compliance with the GDPR and the requirements of the European health authorities. Each study instance benefits from an isolated environment, complete access traceability and a daily encrypted backup.

In terms of CDISC standards, Exagis natively produces exports compliant with CDASH for collection and SDTM for regulatory submission. Our teams handle the mapping of data to these formats without any specific development on the client side, which significantly reduces submission timelines with the EMA or the FDA.

International deployment and multilingual support

Exagis is available in 11 languages, which makes it a particularly well-suited tool for international multicentre trials. The investigator interface can be configured language by language and country by country, without altering the study structure or the validation rules.

This flexibility directly benefits sponsors whose sites are spread across France, Germany, the United States, Canada or the Nordic countries. A single central configuration, with localised instances by site or by country: Axiodis manages the entire deployment.

The ePRO and REPORT modules

The ePRO module allows patients to enter their data directly from a smartphone or tablet, with no app to install. The questionnaires are configured in Exagis and accessed through a secure link, which removes the logistical constraints of paper and improves the completeness of patient-reported data.

The REPORT module gives sponsors real-time access to the study progress dashboards: completion rate by site, number of open queries, average resolution time and the key indicators of the monitoring plan. This data is updated continuously and accessible with no software to install.

Who is Exagis designed for?

Exagis is aimed primarily at academic sponsors (university hospitals, research institutes), biotechs and small pharmaceutical organisations looking for a turnkey, scalable solution with no hidden licence costs. Axiodis offers a platform access package included in the overall service, with initial configuration in under five working days for standard protocols.

If you would like to evaluate Exagis for your next trial, our team is available for a personalised demonstration.